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Food Importers Need to Tell FDA About Any Refused Entries

Some rules to implement the Food Safety Modernization Act (FSMA) are controversial and some are not.

One designed to stop possibly contaminated food from getting into the United States becomes permanently effective today with its publication in the Federal Register. It says that if food for import to the U.S. has been refused entry by another country, the U.S. Food and Drug Administration (FDA) needs to know and food importers need to tell.

The reason the new rule is not likely to generate much controversy is that it’s been in effect as an interim rule under the FSMA without much controversy. And its origin dates back to 2002 as a post 9/11 requirement.

In keeping potentially dangerous food out of the country, FDA will use the actions of other countries to help determine which imports to inspect. And in publishing the final rule today, FDA provided importers with details on when the reporting obligation kicks in.

“For purposes of this regulation, FDA considers ‘refused entry’ to mean a refusal of entry or admission of human or animal food based on food safety reasons, such as intentional or unintentional contamination of an article of food,” the rule says. “This is consistent with the intent of the provision, which is to provide FDA with additional information to better identify imported food shipments that may pose a safety or security risk to U.S. consumers.”

The importer providing the information to FDA doesn’t have to provide the reason another country refused entry for food destined for the USA. FDA may pursue the reason for the refusal.

FDA will continue to target food imports that “may pose a significant risk to public health.”

FDA’s “prior notice of imported foods” has been in effect as an interim rule since May 2011. The final rule taking effect today is identical to the interim rule.

Before its adoption as a final rule, FDA said only about 15 comments had been received and most of those sought a clarification of terms such as “refused entry.” FDA officials say any refusal for food safety reasons, whether intentional or unintentional contamination. They stressed they want only to hear about food safety related refusals from persons with knowledge about it.

Since February, FDA has also been able to, under the FSMA, administratively detain food it believes is adulterated or misbranded without yet having actual evidence.